[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

925-954-4868

Email address

lvondollen@neurocentria.com

Condition

Alzheimer Disease

Treatment type

Interventional

Investigational product

MMFS-205-SR

Phase

Phase 2

Sponsor

Neurocentria, Inc.

ClinicalTrials.gov identifier

NCT03531684

Study number

NC007

Understanding clinical trials

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About the study

This study is designed to evaluate the safety and efficacy of MMFS for improving cognition and global function in patients with probable mild Alzheimer's disease.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Diagnosis of probable Alzheimer's disease (AD)
  2. ≥ 60 and ≤ 85 years old at screening
  3. Systolic blood pressure below 150
  4. Total body weight (bw) must be ≥50 kg and ≤100 kg, and lean body mass (LBM) must be ≤ 85 kg
  5. Mini Mental State Examination (MMSE) = 18-24
  6. Clinical Dementia Rating: home & hobbies, personal care, or community affairs > 0.
  7. Neuropsychiatric Inventory (NPI) 12-item score ≥ 7, with following criteria:
  8. NPI score for inclusion cannot be only from Apathy/Indifference and/or Appetite and Eating Disorders categories
  9. Symptoms cannot due to recent life event (accident, loss of loved one, environmental disturbance, etc.)
  10. if baseline visit is within 14 days of screen visit, screen visit NPI score can be used as baseline NPI score
  11. Evidence of recent-onset symptoms and progressive decline occurring after the age 55
  12. Cognitive concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
  13. Apart from clinical diagnosis of Mild AD, subject must be in good health and capable of completing all study requirements
  14. Must be fluent in English
  15. Must have a friend/family member who frequently spends time with the subject (≥10 hours per week), and is willing to serve as an informant, and accompany the subject to, and participate in, all laboratory visits
  16. Completion of at least 12 years of formal education (i.e., possess high school diploma, GED, or equivalent)
  17. Hearing and vision ability sufficient to complete neurocognitive testing
Exclusion criteria
  1. Females of child-bearing potential, as defined as menstruation within past 12 months. Surgically sterile is considered not of child-bearing potential
  2. Severe physical disability not associated with cognitive function that limits ability to complete neurocognitive testing (e.g., severe tremor, debilitating arthritis)
  3. History of evidence of acute or sub-acute micro or macrohemorrhage, greater than 4 microhemorrhages, cortical infarct, or greater than one 1 lunar infarct
  4. Evidence of vascular dementia (Modified Hachinski Ischemia Scale score >5)
  5. Stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year)
  6. Seizure in the past 3 years
  7. An affirmative response on the C-SSRS, indicating suicidal ideation with intent, with or without a plan or method, or suicidal behavior, in the past 6 months.
  8. Clinically significant psychiatric illness in past 6 months requiring hospitalization
  9. History or diagnosis of any of the following sleep conditions:
  10. Narcolepsy
  11. Cataplexy (familial or idiopathic)
  12. Circadian Rhythm Sleep Disorder
  13. Primary Hypersomnia
  14. Diagnosed with apnea but not using Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BIPAP). If diagnosed with apnea, subject must maintain use of device throughout study
  15. History of clinically important carotid or vertebrobasilar stenosis or plaque
  16. Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia; congenital QT prolongation
  17. Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
  18. Significant systematic illness or infection in past 30 days
  19. Poor kidney function; estimated glomerular filtration rate (eGFR) <55
  20. Currently living in an institutional facility such as a nursing home
  21. Alcohol or substance abuse in past 1 year
  22. Changes in medications or doses of medication in past 3 months
  23. All allowed concomitant medications, supplements, or other substances must be at stable doses for at least 3 months prior to screening, and must be kept as stable as medically possible during the trial. If a change in medication dosage occurs during the study, this will lead to discontinuation from study participation unless it relates to a medication that, in the view of the study investigator, does not affect participation in the trial.
  24. Use of prohibited medications/substances

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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